Clinical Trial: CMV-CTL for the Treatment of CMV Infection After HSCT

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cytomegalovirus Specific Cytotoxic T Lymphocyte for the Treatment of Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation

Brief Summary:

Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte (CMV-CTL) given to transplant recipients

CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived from donor peripheral blood mononuclear cells for a period of 18~21 days.The patients will receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA level will be monitored weekly after transfusion.


Detailed Summary:

Allogeneic hematopoietic stem cell transplantation is widely used for the treatment of hematological malignancies and bone marrow failure diseases. Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Approximately half of the recipients would develop CMV infection after transplant. Present treatment recommendation for CMV infection including ganciclovir and foscarnet. However, these medications have many side effects, the most serious is myelosuppression and renal injury, moreover, many patients do not response to these medications. Considering the risk associated with persistent infection and the potential for CMV specific cytotoxic T lymphocyte (CMV-CTL) to restore immunity, we propose to study the immunologic and virologic effects of donor derived CMV-CTL given to transplant recipients, levels of CMV-CTL and CMV DNA will be measured from CTL recipients.

If the patient and their donor are eligible, we will take 80 ml of fresh blood from the donor or 5 ml peripheral blood stem cell from the donor.The peripheral blood mononuclear cells will be separated from peripheral blood or peripheral blood stem cell. CMV antigen peptides will be used to induce the CMV-CTL for a period of 18~21 days.

The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA levels will be monitored weekly for at least 60 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive one additional injection of CTLs. If the CMV levels in the blood continue to rise after the dose of T cells then the patient wil
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: 30-day response rate [ Time Frame: from the date of CMV-CTL infusion to 30 days after the infusion ]

CMV-DNA copies/ml serum


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1-year overall survival [ Time Frame: from the date of transplant to 1 year after transplant ]
  • 100-day incidence of acute GVHD [ Time Frame: from the date of transplant to 100 days after transplant ]
    the incidence of acute GVHD
  • 1-year incidence of chronic GVHD [ Time Frame: from the date of transplant to 1 year after transplant ]
    the incidence of chronic GVHD


Original Secondary Outcome: Same as current

Information By: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: December 18, 2016
Date Started: November 2016
Date Completion: December 31, 2019
Last Updated: February 24, 2017
Last Verified: February 2017